NCT02450214

Brief Summary

Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs) are insufficient, while opioids are avoided by their adverse effects and regional techniques are hampered by a premature discharge. In this context, the investigators seek an intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus magnesium to significantly decrease postoperative pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

May 18, 2015

Last Update Submit

May 1, 2018

Conditions

Pain, Postoperative

Keywords

KetamineMagnesiumAnalgesiaLiposuctionLipoabdominoplastyPreemptive analgesia

Outcome Measures

Primary Outcomes (2)

  • Opioids consumption

    12 h after surgery

  • Postoperative Pain (Postoperative Pain and Disability Scale)

    Postoperative Pain and Disability Scale (Body-PPDS) will be used to quantify pain

    2, 7, 14, 21, 45 and 90 days after surgery

Secondary Outcomes (4)

  • Early postoperative pain (Visual analogue pain scale)

    0, 2, 4, 6, 12 and 24 h after surgery

  • Early postoperative pain (Time to first request for supplemental analgesia)

    1 day

  • Disability (Time delay in returning to work)

    90 days

  • Postoperative Chronic Pain (McGill scale)

    Day after surgery, 7, 30 and 90 days after surgery

Other Outcomes (2)

  • Drug Side Effect

    First day after surgery

  • Other Variables

    First day

Study Arms (3)

Control group (C)

SHAM COMPARATOR

50 mL syringe with saline, plus 1 flask of 100 mL saline (Saline)

Drug: Saline

Ketamine group (K)

EXPERIMENTAL

50 mL syringe with ketamine (50mg / 50ml), plus 1 flask of 100 mL saline (Ketamine)

Drug: Ketamine

Magnesium + ketamine group (MGK)

EXPERIMENTAL

50mL syringe with ketamine (50mg / 50ml), plus a flask of 100ml of saline with 5 g of magnesium sulfate (Ketamine + magnesium)

Drug: Ketamine + magnesium

Interventions

SalineDRUG

50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h

Control group (C)
KetamineDRUG

50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h

Ketamine group (K)
Ketamine + magnesiumDRUG

50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h

Magnesium + ketamine group (MGK)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male
  • years or older
  • Liposuction and lipoabdominoplasty
  • ASA 1 and 2
  • BMI 21-28 Kg/m2
  • Full secondary education

You may not qualify if:

  • Patients with surgeries added to the main proceedings
  • Scheduled to tuck in Flor de Lis or Body Lift
  • History of use of analgesic drugs 48 hours before surgery
  • Peripheral central neurological diseases
  • Known allergy will be excluded to medication in use in this study (ketamine, magnesium, clindamycin and penicillin or other)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Sodium ChlorideKetamineMagnesium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMetals, Alkaline EarthElementsMetals, LightMetals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 21, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 2, 2018

Record last verified: 2016-10

Locations

CL(1)